Back in February, ICON mobilized its vaccine resources to address the COVID-19 global pandemic, including its ability to conduct home-based trials to minimize infection. The company is currently providing clinical monitoring and safety oversight on a number of COVID-19 trials for both the private and government sectors. These include a prophylactic vaccine study in healthy participants, and a study investigating antiviral treatment for patients with Coronavirus infection.

Contract Pharma:What significant developments have been made in vaccine research efforts?

James Cummings: Over the past decade, researchers have made great strides in vaccine research with gene sequencing, further development of mRNA and DNA vaccine platforms, and novel adjuvants for more traditional antigen based products. These advancements have enabled biopharmaceutical and government entities to respond to infectious disease outbreaks by fast tracking both vaccines and treatments, including monoclonal and polyclonal antibody products, in record time.

In the current pandemic, regulatory agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have expedited commercial approvals to bring safe vaccines and treatments to market. Furthermore, groups such as The Coalition for Epidemic Preparedness Innovations (CEPI) and Biomedical Advanced Research and Development Authority (BARDA) have enabled key assets and infrastructures to be leveraged in response to this pandemic.

ICON has been preparing for this type of response as part of our continual product development and process improvement efforts by employing a build-measure-learn cycle to promote timely, quality responses for our clients.

CP: What are the key development challenges of delivering a coronavirus vaccine?

Beth Tulip: Time. Currently, there are numerous vaccine and therapeutic candidates in the COVID-19 development pipeline. However, there are likely only a few contenders to be developed, tested, and manufactured in time to respond to the potential upcoming waves of this outbreak. Furthermore, reliable and timely diagnostics are fewer and farther between. Without access to sound diagnostics and well-trained site staff at the point of patient care, we would be struggling in our outbreak response. The good news is that COVID-19 diagnostics are being developed and approved every day. ICON has developed COVID-19 specific processes and training modules to facilitate rapid, thorough training for our study teams and best practices to support our sites. ICON works closely with sponsors and regulatory authorities to ensure COVIID-19 prophylaxes and treatments are prioritized and available.

CP: How is the COVID-19 pandemic impacting the conduct of clinical trials?

Beth Tulip: Unfortunately, clinical trial operations of all therapeutic areas are impacted by COVID-19 across the globe.

Site and logistical challenges of operating in the current COVID-19 pandemic are inherent, and becoming increasingly difficult in the execution of clinical trials. There is the potential of infections in the population of participants, as well as in those executing and supporting these clinical trials. A few sponsors are choosing to halt all new studies for now. Other sponsors are looking beyond traditional clinical site visits, with at home and alternative clinical sites visits. Such services also help address patient concerns and hesitancy to visit a hospital or clinic for fear of COVID-19 infection. Sites may be unable to have monitors on site to review clinical trial patient data and others are relying solely on technology to continue to monitor patients. Sponsors are exploring remote monitoring and similar services, such as Direct to patient contact support, much more intensively. The COVID-19 pandemic is acting as an accelerant of the digital disruption that was already underway with clinical trials and pharma generally.

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